BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CMV IGG REAGENT KIT

    MDR report key: 22140461 · Received June 4, 2025

    Report

    Report Number
    3008344661-2025-00081
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 10, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LFZ
    UDI-DI
    00380740129798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION E1 - PHONE NUMBER COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P42-24/-33 AND A 510K/PMA/BLA NUMBER OF K220949.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING OF A RETAINED REAGENT KIT LOT 67106FZ00. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. THE TICKET TRENDING REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. IN-HOUSE TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CMV IGG REAGENT LOT 67106FZ00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I CMV IGG RESULT FOR A PREGNANT FEMALE SAMPLE. IT WAS REPORTED THAT THE PATIENT HAS ALWAYS TESTED NEGATIVE IN OTHER LABORATORIES IN THE PAST FOR CMV IGG. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE >/=6.00 AU/ML IS REACTIVE): (B)(6) 2025 SAMPLE ID (B)(6), INITIAL RESULT = 36.8 AU/ML, (B)(6) 2025 REPEAT RESULT = 0.2 AU/ML. ADDITIONAL LABORATORY DATA PROVIDED: CMV IGM (B)(6) 2025 INITIAL RESULT = 0.78 INDEX, (B)(6) 2025 REPEAT RESULT = 0.80 INDEX (REFERENCE RANGE >/= 1.00 IS REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I CMV IGG RESULT FOR A PREGNANT FEMALE SAMPLE. IT WAS REPORTED THAT THE PATIENT HAS ALWAYS TESTED NEGATIVE IN OTHER LABORATORIES IN THE PAST FOR CMV IGG. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE >/=6.00 AU/ML IS REACTIVE): (B)(6) 2025 SAMPLE ID (B)(6) INITIAL RESULT = 36.8 AU/ML, (B)(6) 2025 REPEAT RESULT = 0.2 AU/ML ADDITIONAL LABORATORY DATA PROVIDED: CMV IGM (B)(6) 2025 INITIAL RESULT = 0.78 INDEX, (B)(6) 2025 REPEAT RESULT = 0.80 INDEX (REFERENCE RANGE >/= 1.00 IS REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673600 ALINITY I CMV IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ABBOTT IRELAND DIAGNOSTICS DIVISION 67106FZ00 00380740129798

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6) | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)